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DRG International, Inc. recalls Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay fo
Recalled August 21, 2024 · FDA recall Z-2622-2024 · DRG International
Hazard
Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients. · FDA Class III
Units
257 units
Sold at
US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
Description
Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.
Product
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
Manufacturer(s)
DRG International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →